The present invention relates to packaging of medical devices, and in particular, devices with adhesive surfaces, such as devices for collecting fecal matter from the anus of a person.
Fecal collection devices which enable collection of feces from incontinent and bedridden patients are generally known. Such devices include a gasket portion for sealing to the anus and a conduit means for permitting discharge from the anus to pass to a receptacle. One such device is disclosed in U.S. Pat. No. 4,784,656 and includes a substantially flat gasket formed of a compliant plastic material which can conform to the anal area and which is coated with an adhesive.
In another type of device which is currently available, the fecal collection device is formed from a very soft elastomeric material coated with adhesive adjacent to an opening. The device is placed using an applicator formed of a generally rigid material, with the applicator and device supplied as a unit. The applicator and device form a generally saddle-shaped gasket, the saddle shape being better designed for fitting the perianal area. The rigid applicator is removed after placement of the device.
The use of a pressure-sensitive adhesive on medical devices requires some type of protection of the adhesive surface prior to use. U.S. Pat. No. 4,784,656 discloses that the adhesive coating is covered by a protective removable release sheet made of a paper having one side coated with a release layer. This release layer is generally made of silicone, although other release materials may be used.
The use of a release sheet in contact with the adhesive surface of a medical device, and in particular, a fecal collection device has been found to be somewhat disadvantageous. The release coating has been found to present a problem with contamination of the adhesive surface, a problem which is magnified because the adhesive surface may be used in contact with sensitive areas of the human body. In addition, the interaction between the release coating and the adhesive may cause difficulties in removing the release liner.
The difficulties involved with use of a release liner have been found to increase when the adhesive contact portion is three dimensional, for example the aforementioned saddle-shape. It is far more difficult to initially apply the release sheet to the saddle-shaped contact portion and far more difficult to sustain over time reliable adherence to a three dimensional surface as opposed to a flat surface. In addition, it is more difficult to cleanly remove the release sheet from the three dimensional surface prior to actual use.